What is the purpose of the viability statement in patent deposits?

What is the purpose of the viability statement in patent deposits?

The viability statement in patent deposits serves to confirm that the deposited biological material is capable of self-replication, either directly or indirectly. According to MPEP 2409, “The term ‘viability’ is specifically defined in the regulations as ‘the capability of a biological material to self-replicate either directly or indirectly.’” This statement is crucial because it ensures that the deposited material can be reliably reproduced, which is essential for the enablement requirement of patents involving biological materials.

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Topics: MPEP 2400 - Biotechnology, MPEP 2409 - Viability Of Deposit, Patent Law, Patent Procedure
Tags: biological material, Patent Deposit, Self-Replication, Viability Statement